Drug product
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
D-0677-2025
Product summary
- Firm
- Apotex Corp.
- Event
- Event 97561
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 493,468 bottles
- Official record key
drug-enforcement:D-0677-2025
Official wording
Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Code information: Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316
Distribution pattern: Nationwide in the US
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility